Abstracts

These are abstracts of some of the white papers and scientific papers you will find inside the DPT Knowledge Center. Please register for access to the entire body of Knowledge Center content.

Inhalation Drug Delivery - Understanding Basic Steps Involved in Pressurized Metered Dose Inhalation (pMDI) Development

Drug delivery via the inhalation route is an efficient, safe and efficacious method for local and systemic administration of certain therapeutic agents. Many inhaled therapeutics are delivered to the lung tissue to elicit a local response, typically for asthma or other lung disorders. However, because of the large surface area and high vascularity of the lungs, it is also an excellent route of administration for systemic drug delivery. This white paper provides insight into the aspects of formulation development, packaging development and analytical development associated with inhaled drug delivery as it relates to pressurized metered dose inhalers (pMDI).

Analytical Method Development and Validation – A CDMO Perspective

Inconsistencies in the analytical method can hinder product and process development, thus delaying submission for regulatory approval and thereby delaying product launch. However, a Contract Development and Manufacturing Organization (CDMO) that understands customer needs, regulatory requirements, and has a proven track record for developing and validating analytical methods can minimize developmental costs and reduce the time to market. Properly validated drug product characterization methods are necessary for regulatory filings, but can also reduce overall turnaround time during scale-up, clinical release and commercial release.

Effective ICH Q8 Pharmaceutical Development Reports

The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications in the U.S., the E.U. and Japan. One significant section of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to providing comprehensive understanding of the product and process for FDA application reviewers. Information in the PDR is based upon the documentation generated during the formulation and process development phase of drug development. The development process should determine how variation of the parameters and attributes can affect the drug product and provide enhanced knowledge of the effects over the variation range of the parameters.

Partnering with Your CDMO for CMC Preparation

Collaborative partnering between CDMOs and drug product submission applicants is becoming increasingly important with the emphasis on product design by regulatory agencies.

Leveraging the product knowledge base of the CDMO for the preparation of the CMC sections can significantly improve the quality of the submission. The effectively-managed alliance between the CDMO CMC preparation team and the Applicant can help meet the regulatory agency expectations for the submission in a timely and efficient manner and ensure that consistent information is being presented to the agency. Integrating the preparation of the CMC into the CDMO development process can streamline the process for both and provide a system for addressing issues as they arise.

Enhancing the Solubility of Poorly Water-Soluble Drugs in the Presence of Nano-Emulsion Particles

Aqueous solubility of drug substances is an important parameter in preformulation studies of a drug product. Several drugs are sparingly water-soluble and pose challenges for formulation and dose administration. Literature indicates that a solution of drug in an organic solvent can be injected into an IV fluid that forms a relatively stable solution of drug for infusion. The current study focuses on the influence of different types of nano-emulsions and the particle size of the nano-emulsion on the solubility of different APIs.